Actively Recruiting
Estimate the Risk of Diabetic and Uremic Peripheral Neuropathy Using Physical and Functional Testing
Led by Université catholique de l'Ouest · Updated on 2025-04-18
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Université catholique de l'Ouest
Lead Sponsor
C
Centre Hospitalier le Mans
Collaborating Sponsor
AI-Summary
What this Trial Is About
Diabetes and chronic kidney disease (CKD) are separate health conditions that both frequently lead to peripheral neuropathy, a nerve disorder causing pain and reduced muscle strength. This research focuses on using physical and balance tests during regular care to predict the risk of peripheral neuropathy in people aged 60 to 80 with diabetes or CKD. The study aims to improve early and reliable detection, as current clinical and laboratory tests have limitations and inconsistencies. This observational study does not involve drug treatments but evaluates participants through functional testing that measures balance and physical abilities. These assessments include analyzing postural balance using stabilometric methods and measuring the time a person can balance on one leg. By combining these functional measures, researchers hope to create a composite score that can predict peripheral neuropathy risk more accurately than existing tests. Participants will undergo these balance and physical tests as part of routine care in adapted physical activity settings. Researchers will collect data at baseline to develop a statistical model for the composite score. This approach aims to provide an objective, early marker of neuropathic impairment. The study will monitor participants' functional capacities without intervention, and participation is expected to last for the duration of the study period starting in early 2025.
CONDITIONS
Brief Title
Prediction of Peripheral Neuropathy With Functional Testing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have stage 4 or 5 chronic kidney disease and/or type 1 or type 2 diabetes
- Able to walk 20 meters
- Body mass index (BMI) less than 35
- Aged between 60 and 80 years old
You will not qualify if you...
- Currently undergoing or planning to start dialysis treatment
- Have musculoskeletal, joint, or neurological diseases
- Have cognitive impairment
- Have had a lower limb amputation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline
Participants undergo physical and functional testing to assess risk of peripheral neuropathy.
1 visit (in-person)
Duration - Up to study completion in May 2025
Participants are observed over time to monitor progression of peripheral neuropathy risk.
Visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Le Mans
Le Mans, France, 72000
Actively Recruiting
Research Team
G
Giorgina Barbara Piccoli, Professor, Medical Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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